Objective:To explore influence of risk factors of ischemic cerebral stroke (ICS)on its onset.Methods:A total of 350 patients diagnosed as ICS were selected as stroke group among 12241 >40 years people from Dongli dis- trict of Harbin city,another 350 >40 years non-ICS people,who were randomly selected from the same district, were enrolled as control group.ICS risk factors were compared between two groups,multi-factor Logistic regres- sion analysis was used to analyze independent risk factors for ICS.Results:(1)There were no significant difference in age,nationality,education,marriage and professions between two groups except food taste (P<0.01); (2) Multifactor Logistic regression analysis indicated that hypertension (OR=5.853,95%CI:3.188~10.673),hyper- lipidemia (OR=5.601,95%CI:2.378~ 9.635),carotid artery plaque (OR=4.963,95%CI:2.350~9.843), heart disease (OR=4.568,95%CI:2.535~7.745),hyperhomocysteinemia (OR=4.076,95%CI:3.001~8.270), apparent overweight (OR=3.421,95%CI:1.598~6.476)and family history of cerebrovascular diseases (OR=3.065,95%CI:2.543~4.236)were independent risk factors for ICS in both groups (P<0.01 all).According to OR value from big to small,risk factors for ICS were hypertension,hyperlipidemia,carotid artery plaque,heart disease,hyperhomocysteinemia,apparent weight and family history of cerebrovascular diseases respectively.Conclu-sion:Besides traditional risk factors like hypertension,dyslipidemia and family history of cerebrovascular diseases, other risk factors such as carotid artery plaque,heart disease,family history of cerebrovascular disease and apparent overweight are also important risk factors for stroke.

Objective:To explore advantage of intravascular ultrasound (IVUS) guiding coronary intervention .Meth‐ods:A total of 100 patients with left main (LM) lesion were selected and equally divided into IVUS group (n=50 , received stent implantation under IVUS guidance ) and control group [n=50 ,received stent implantation after coro‐nary angiography (CAG) evaluation without IVUS examination ) .Instant condition after stent implantation and fol‐low-up results after 12 months were compared between two groups .Results:There were no significant difference in general data ,percentages of LM opening ,body part and tail lesions ,different types of plaques between two groups , P>0.05 all .During hospitalization ,there were no significant difference in percentage of emergency coro‐nary artery bypass grafting (0% vs .4% ) and mortality (0% vs .4% ) between IVUS group and control group (P>0.05) .However ,after 12 months ,compared with control group ,there were significant reductions in incidence rates of in-stent restenosis (16% vs .4% ) and late stent malapposition (34% vs .6% ) in IVUS group , P< 0.05 ,<0.01. Conclusion:IVUS guiding left main lesion intervention is helps to select more appropriate therapeutic plan , reduce tissue injury and improve long -term therapeutic effect .

OBJECTIVE：To standardize and optim ize the clinical use of Trastuzumab for injection ，and to provide reference for rational use of drugs in the patients. METHODS ：The pharmacy intravenous admixture service （PIVAS）in our hospital took the lead in communication and coordination with financial ，information，medical insurance departments as well as clinicians and nurses，to set up dispensing ，charging and reimbursement mode by dose of trastuzumab. Under that ，doctors could give orders according to the clinical dosage of patients ；PIVAS dispenses drugs according to the actual dose ；the drugs were shared among patients；the charge and reimbursement of drugs are carried out according to the actual dose of patients. At the same time ，the questionnaire survey was conducted among 60 patients about the medical experience and cost savings before and after the implementation of the mode . RESULTS ：The questionnaire survey showed that in terms of solving the potential safety problems of trastuzumab and the inconvenience of patients ’medical treatment ，the solution rate of the mode was 100％；in terms of improving patients’feeling of seeking medical treatment and helping treatment ，the improvement rate was 100％；in terms of saving patients ’ treatment costs ，most（80％）of the patients thought that it could save less than 500 yuan each time ，and rest of the patients thought that it could save more than 500 yuan each time. CONCLUSIONS ：The mode of dispensing ，charging and reimbursement of Trastuzumab for injection in our hospital has solved the problems of drug waste ，occupational injury and inconvenient preservation in clinical use ，and has played a good role in drug safety ，cost saving and patient convenience.

Objective:To evaluate the cost effectiveness of primary prophylaxis (PP) with pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF), PP with recombinant human granulocyte colony stimulating factor (rhG-CSF) and no prophylaxis in women with early-stage breast cancer in China.Methods:Two phase Markov models were constructed for a hypothetical cohort of patients aged 45 with stage Ⅱ breast cancer. The first phase modelled costs and outcomes of 4 cycles docetaxel combined with cyclophosphamide [TC×4, febrile neutropenia (FN) risk>20%] chemotherapy, which assumptions based on literature reviews, including FN rates [base-case (deterministic sensitivity analysis range), 0.29 (0.24-0.35)] and related events [FN case-fatality, 3.4 (2.7-4.1)]. Second phase modelled the long term survival which was link with the relative dose intensity (RDI) [mortality hazard ratio ( HR) of RDI < 85% vs ≥85%, 1.45 (1.00-2.32)]. Clinical effectiveness, therapeutic costs, and economic utilities were estimated from peer-reviewed publications and expert opinions in case of unavailability of published evidences. Results:Compared to rhG-CSF PP and no prophylaxis, the cost of PEG-rhG-CSF PP increased to 5 208.19 RMB and 5 222.73 RMB, respectively. The quality-adjusted life-years (QALYs) enhanced to 0.066 and 0.297, respectively. Accordingly, the incremental cost effectiveness ratios (ICERs) are 79 146.3 RMB and 17 558.77 RMB per QALY, which were both below the willingness to pay (WTP) threshold of three times GDP per capita (18, 000 RMB) recommended by the WHO. Sensitivity analysis suggested that the more clinically effective the primary prophylaxis with PEG-rhG-CSF is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. And the lower the mortality HR of RDI<85% vs ≥85% is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. Conclusion:Although the cost of PP PEG-rhG-CSF is higher, considering the additional benefits, the administrating of PP PEG-rhG-CSF is likely to be a cost-effective alternative to PP rhG-CSF and no prophylaxis in patients with early stage breast cancer whose FN risks are more than 20% in China.

Purpose: This study aims to evaluate the efficacy and safety of a new combination treatment of vinorelbine and pyrotinib in human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer (MBC) and provide higher level evidence for clinical practice. Materials and Methods: This was a prospective, single-arm, phase 2 trial conducted at three institutions in China. Patients with HER2-positive MBC, who had previously been treated with trastuzumab plus a taxane or trastuzumab plus pertuzumab combined with a chemotherapeutic agent, were enrolled between March 2020 and December 2021. All patients received pyrotinib 400 mg orally once daily plus vinorelbine 25 mg/m2 intravenously or 60-80 mg/m2 orally on day 1 and day 8 of 21-day cycle. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included the objective response rate (ORR), disease control rate (DCR), overall survival, and safety. Results: A total of 39 patients were enrolled. All patients had been pretreated with trastuzumab and 23.1% (n=9) of them had accepted trastuzumab plus pertuzumab. The median follow-up time was 16.3 months (95% confidence interval [CI], 5.3 to 27.2), and the median PFS was 6.4 months (95% CI, 4.0 to 8.8). The ORR was 43.6% (95% CI, 27.8% to 60.4%) and the DCR was 84.6% (95% CI, 69.5% to 94.1%). The median PFS of patients with versus without prior pertuzumab treatment was 4.6 and 8.3 months (p=0.017). The most common grade 3/4 adverse events were diarrhea (28.2%), neutrophil count decreased (15.4%), white blood cell count decreased (7.7%), vomiting (5.1%), and anemia (2.6%). Conclusion Pyrotinib plus vinorelbine showed promising efficacy and tolerable toxicity as second-line treatment in patients with HER2-positive MBC.

Objective:To evaluate the cost effectiveness of primary prophylaxis (PP) with pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF), PP with recombinant human granulocyte colony stimulating factor (rhG-CSF) and no prophylaxis in women with early-stage breast cancer in China.Methods:Two phase Markov models were constructed for a hypothetical cohort of patients aged 45 with stage Ⅱ breast cancer. The first phase modelled costs and outcomes of 4 cycles docetaxel combined with cyclophosphamide [TC×4, febrile neutropenia (FN) risk>20%] chemotherapy, which assumptions based on literature reviews, including FN rates [base-case (deterministic sensitivity analysis range), 0.29 (0.24-0.35)] and related events [FN case-fatality, 3.4 (2.7-4.1)]. Second phase modelled the long term survival which was link with the relative dose intensity (RDI) [mortality hazard ratio ( HR) of RDI < 85% vs ≥85%, 1.45 (1.00-2.32)]. Clinical effectiveness, therapeutic costs, and economic utilities were estimated from peer-reviewed publications and expert opinions in case of unavailability of published evidences. Results:Compared to rhG-CSF PP and no prophylaxis, the cost of PEG-rhG-CSF PP increased to 5 208.19 RMB and 5 222.73 RMB, respectively. The quality-adjusted life-years (QALYs) enhanced to 0.066 and 0.297, respectively. Accordingly, the incremental cost effectiveness ratios (ICERs) are 79 146.3 RMB and 17 558.77 RMB per QALY, which were both below the willingness to pay (WTP) threshold of three times GDP per capita (18, 000 RMB) recommended by the WHO. Sensitivity analysis suggested that the more clinically effective the primary prophylaxis with PEG-rhG-CSF is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. And the lower the mortality HR of RDI<85% vs ≥85% is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. Conclusion:Although the cost of PP PEG-rhG-CSF is higher, considering the additional benefits, the administrating of PP PEG-rhG-CSF is likely to be a cost-effective alternative to PP rhG-CSF and no prophylaxis in patients with early stage breast cancer whose FN risks are more than 20% in China.

Drugs under special management include narcotic drugs,psychotropic drugs,toxic drugs for medical use,radiopharmaceuticals,and pharmaceutical precursor chemicals.Supervising and guiding the clinical use of drugs under special management is one of the important responsibilities of the Pharmaceutical Management and Drug Therapy Committee(Group)of medical institutions.The standard for drugs under special management is led by the Pharmaceutical Professional Committee of the China Hospital Association,which standardizes 16 key elements of organizational management,process management,and quality control management drugs under special management in medical institutions.It can guide the standardized implementation of Pharmaceuticals under special control work in various levels and types of medical institutions.This article elaborates on the methods and contents of formulating standards for Pharmaceuticals under special management,to provide reference and inspiration for medical institutions to carry out special drug drug management and daily related work.

OBJECTIVETo systematically evaluate the efficacy and safety of acupuncture on diarrhea-predominant irritable bowel syndrome (IBS) in the past five years.

METHODSOnline databases, including CNKI, VIP, WANFANG, PubMed, CBM, ScienceDirect OnSite, Cochrane Library, etc. were searched for randomized controlled trials (RCTs) of acupuncture for diarrhea-predominant IBS. Retrieval time was from January of 2011 to January of 2016. According to modified Jadad standard, the bias risk and quality assessment of each RCT included were evaluated by two researchers. RevMan 5.3 software was adopted for the meta-analysis.

RESULTSTotally 17 RCTs were included with 1 333 patients. The result of meta-analysis indicated the total effective rate of clinical symptoms improvement in the acupuncture group or acupuncture combined with western medicine group was superior to that in the western medicine group (=3.92, 95%:2.83~5.43,<0.01), and the funnel plot was basically symmetry. The result of meta-analysis showed 3-month recurrence rate:=0.22, 95%:0.12~0.41 (<0.01), indicating the recurrence rate in the acupuncture group was lower than that in the western medicine group in three month.

CONCLUSIONSAcupuncture for diarrhea-predominant irritable bowel syndrome is superior to conventional treatment of western medication, which can improve the clinical symptoms and reduce the recurrence rate of patients.